QSYMIA Drug Patent Profile
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When do Qsymia patents expire, and what generic alternatives are available?
Qsymia is a drug marketed by Vivus and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has forty patent family members in seventeen countries.
The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.
DrugPatentWatch® Generic Entry Outlook for Qsymia
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 9, 2028. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for QSYMIA
International Patents: | 40 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 14 |
Patent Applications: | 1 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for QSYMIA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QSYMIA |
What excipients (inactive ingredients) are in QSYMIA? | QSYMIA excipients list |
DailyMed Link: | QSYMIA at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for QSYMIA
Generic Entry Date for QSYMIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for QSYMIA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
VIVUS LLC | Phase 4 |
University of Minnesota | Phase 2 |
The Cleveland Clinic | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for QSYMIA
Paragraph IV (Patent) Challenges for QSYMIA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
QSYMIA | Extended-release Capsules | phentermine hydrochloride; topiramate | 3.75 mg/23 mg 7.5 mg/46 mg 11.25 mg/69 mg 15 mg/92 mg | 022580 | 1 | 2013-07-18 |
US Patents and Regulatory Information for QSYMIA
QSYMIA is protected by six US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of QSYMIA is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting QSYMIA
Low dose topiramate/phentermine composition and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Escalating dosing regimen for effecting weight loss and treating obesity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
Escalating dosing regimen for effecting weight loss and treating obesity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
Low dose topiramate/phentermine composition and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Low dose topiramate/phentermine composition and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Escalating dosing regimen for effecting weight loss and treating obesity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-001 | Jul 17, 2012 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for QSYMIA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | See Plans and Pricing | See Plans and Pricing |
Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-002 | Jul 17, 2012 | See Plans and Pricing | See Plans and Pricing |
Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-001 | Jul 17, 2012 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for QSYMIA
When does loss-of-exclusivity occur for QSYMIA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 09257572
Estimated Expiration: See Plans and Pricing
Patent: 09257573
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0914985
Estimated Expiration: See Plans and Pricing
Patent: 0914991
Estimated Expiration: See Plans and Pricing
Canada
Patent: 27313
Estimated Expiration: See Plans and Pricing
Patent: 27319
Estimated Expiration: See Plans and Pricing
Chile
Patent: 10001365
Estimated Expiration: See Plans and Pricing
Patent: 10001366
Estimated Expiration: See Plans and Pricing
China
Patent: 2112126
Estimated Expiration: See Plans and Pricing
Patent: 2112127
Estimated Expiration: See Plans and Pricing
Patent: 4825477
Estimated Expiration: See Plans and Pricing
Patent: 5534921
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 18103
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 17997
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 00002
Estimated Expiration: See Plans and Pricing
Patent: 17997
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 13489
Estimated Expiration: See Plans and Pricing
Israel
Patent: 9874
Estimated Expiration: See Plans and Pricing
Patent: 9875
Estimated Expiration: See Plans and Pricing
Japan
Patent: 52595
Estimated Expiration: See Plans and Pricing
Patent: 77053
Estimated Expiration: See Plans and Pricing
Patent: 14750
Estimated Expiration: See Plans and Pricing
Patent: 11522896
Estimated Expiration: See Plans and Pricing
Patent: 11522897
Estimated Expiration: See Plans and Pricing
Patent: 15166380
Estimated Expiration: See Plans and Pricing
Patent: 16006085
Estimated Expiration: See Plans and Pricing
Patent: 17078083
Estimated Expiration: See Plans and Pricing
Patent: 17105788
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 2684
Estimated Expiration: See Plans and Pricing
Patent: 10013503
Estimated Expiration: See Plans and Pricing
Patent: 10013505
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 17997
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1008839
Estimated Expiration: See Plans and Pricing
Patent: 1008840
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 110042280
Estimated Expiration: See Plans and Pricing
Patent: 110044847
Estimated Expiration: See Plans and Pricing
Patent: 140121491
Estimated Expiration: See Plans and Pricing
Spain
Patent: 06041
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering QSYMIA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 201008840 | ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY | See Plans and Pricing |
Norway | 317754 | See Plans and Pricing | |
Spain | 2184127 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for QSYMIA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2317997 | CA 2021 00049 | Denmark | See Plans and Pricing | PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |